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Titlebook: Quantitative Decisions in Drug Development; Christy Chuang-Stein,Simon Kirby Book 20171st edition Springer International Publishing AG 201

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書目名稱Quantitative Decisions in Drug Development
編輯Christy Chuang-Stein,Simon Kirby
視頻videohttp://file.papertrans.cn/781/780823/780823.mp4
概述Focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug.Takes a holistic approach towards drug development by incorporating k
叢書名稱Springer Series in Pharmaceutical Statistics
圖書封面Titlebook: Quantitative Decisions in Drug Development; Christy Chuang-Stein,Simon Kirby Book 20171st edition Springer International Publishing AG 201
描述.This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to?incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria,?determining go/no-go decisions for progressing a drug candidate to the next stage and?predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm..The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development processand the clinical trials conducted to support drug-marketing authorization.. .The authors provide software codes for select?analytical approaches discussed in the book. The book includes enough technical details to allow stat
出版日期Book 20171st edition
關(guān)鍵詞clinical trials; metric for decision; drug development; probability of study success; probability of pro
版次1
doihttps://doi.org/10.1007/978-3-319-46076-5
isbn_softcover978-3-319-83434-4
isbn_ebook978-3-319-46076-5Series ISSN 2366-8695 Series E-ISSN 2366-8709
issn_series 2366-8695
copyrightSpringer International Publishing AG 2017
The information of publication is updating

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Characteristics of a Diagnostic Test,nt years, companion diagnostics have been developed to preselect patients for specific treatments based on their own biology. In this chapter, we review the metrics commonly used to characterize the performance of a diagnostic test. We then discuss what it means when a diagnostic test returns a posi
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The Parallel Between Clinical Trials and Diagnostic Tests,on to diagnose is whether the new drug has a clinically meaningful efficacious effect. This comparison offers us the opportunity to apply properties pertaining to diagnostic tests discussed in Chap. 3 to clinical trials. Building on the results in Chap. 3, we discuss why replication is such a critic
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Incorporating Information from Completed Trials in Future Trial Planning,onsider the Bayesian approach to incorporate existing information into future trial planning. Under the Bayesian approach, prior distributions are used to describe the accumulated knowledge about unknown parameters such as those representing treatment effects. The prior distributions are then used t
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Designing Proof-of-Concept Trials with Desired Characteristics,patients, and if the drug appears to have an effect, whether the size of the effect warrants investment in further development. A number of approaches have been proposed to make a decision for a POC study. In this chapter we review five of them. They are, the traditional hypothesis testing approach,
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